Cleared Traditional

AeviceMD

K243603 · Aevice Health Pte. , Ltd. · Anesthesiology
May 2025
Decision
165d
Days
Class 2
Risk

About This 510(k) Submission

K243603 is an FDA 510(k) clearance for the AeviceMD, a Recorder, Magnetic Tape, Medical (Class II — Special Controls, product code DSH), submitted by Aevice Health Pte. , Ltd. (Singapore, SG). The FDA issued a Cleared decision on May 5, 2025, 165 days after receiving the submission on November 21, 2024. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 870.2800.

Submission Details

510(k) Number K243603 FDA.gov
FDA Decision Cleared SESE
Date Received November 21, 2024
Decision Date May 05, 2025
Days to Decision 165 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code DSH — Recorder, Magnetic Tape, Medical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2800